Status:
COMPLETED
Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Shire
Conditions:
Bipolar Disorder
Mania
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. The ...
Detailed Description
Initial clinical evidence suggests that carbamazepine (CBZ) may play a therapeutic role in the management of pediatric bipolar disorder. A recent study found that nearly 50% of patients taking immedia...
Eligibility Criteria
Inclusion
- Male or female subjects, 6-12 years of age.
- Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and structured diagnostic interview (Kidd Schedule of Affective Disorders and Schizophrenia Epidemiological Version)(Kaufman, Birmaher et al. 1997). Bipolar Spectrum Disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
- Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and their legal representative must be considered reliable.
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
- Subjects must have an initial score on the Y-MRS total score of at least 20.
- Subject must be able to participate in mandatory blood draws.
- Subject must be able to swallow pills.
- Subjects with comorbid ADHD, ODD, CD, anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of the exclusionary criteria.
- For concomitant therapy used to treat ADHD, subjects must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy will not change throughout the duration of the study. Strattera will not be allowed.
Exclusion
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Uncorrected hypothyroidism or hyperthyroidism.
- History of sensitivity to carbamazepine or known sensitivity to any of the tricyclic compounds such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. Severe allergies or multiple adverse drug reactions.
- Non-febrile seizures without a clear and resolved etiology.
- History of previous bone marrow depression
- DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.
- Judged clinically to be at serious suicidal risk.
- Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
- A non-responder or a history of intolerance to carbamazepine on an adequate trial (2 months or more at an adequate dose) as determined by the clinician.
- Current diagnosis of schizophrenia.
- Pregnant or nursing females.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00181870
Start Date
July 1 2005
Last Update
June 22 2010
Active Locations (1)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138